Detaillierte Beitrags-Information
| Beitragstitel | Corneal cross-linking for infectious keratitis - results of the prospective multicenter randomized controlled trial |
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| Präsentationsform | Free Paper |
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| Abstract-Text |
Purpose: Severe visual impairment due to corneal infection is a major cause of global blindness. The socioeconomic costs related to corneal ulcers are immense. PACK-CXL (photoactivated chromophore for infectious keratitis-corneal cross- linking), in contrast, does not require expensive medication, but rather Vitamin B2 solution and a light source. Also, PACK-CXL is efficient in antibiotic-resistant and mixed infections. Our objective was to assess the time to corneal epithelization with PACK-CXL as a first-line treatment in infectious corneal ulcers, and compare it to the current standard of care, antimicrobial therapy. Setting: This study was conducted jointly by the Center for Applied Biotechnology and Molecular Medicine at the University of Zurich (Zurich, Switzerland), the Narayana Nethralaya Eye Hospital (Bangalore, India), the Ben-Gurion University of the Negev Sheva (Beer-Sheva, Israel) and the Wenzhou Medical University (Wenzhou, China). Methods: Prospective, interventional, multicenter, randomized controlled phase-III clinical trial. Inclusion criteria were infiltrates and ulcers up to 4mm in diameter and 350μm depth. Antimicrobial therapy, if present, was interrupted overnight prior to treatment. Patients were randomized into PACK-CXL only or medication only. In the PACK-CXL group, a total energy of 7.2J/cm2 was applied, whereas the medication group received the current standard of care according to AAO guidelines. Primary outcome measure was time to re-epithelialization. Results: 30 patients were included, 14 in the PACK-CXL, and 16 in the medication group. One patient in the medication group (corneal perforation) and two patients from the PACK-CXL (required additional antimicrobial therapy) were excluded. Gram-positive cocci were the most commonly identified pathogens. One case of filamentous fungal keratitis (Aspergillus) was identified in one eye treated with PACK-CXL. No significant differences in corneal re-epithelization time were observed between the groups (respectively, 11.18.4 vs 7.05.5 days, p = 0.166). Conclusions: PACK-CXL may be an alternative stand-alone treatment for infectious corneal infiltrates and early corneal ulcers. Even with a (non-significant) tendency for longer healing, 85% of eyes treated with PACK-CXL healed without the use of additional antimicrobial therapy. While these preliminary results are promising, a larger sample is needed to further investigate the efficacy and safety of this treatment modality. |